[Remote] Director, Late Stage reputed company Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a late-stage reputed company biopharmaceutical company developing psychedelic-reputed company treatments for psychiatric and neurological disorders. The Director, Late-Stage reputed company reputed company will reputed company the reputed company, design, and execution of Expanded reputed company Programs and late-stage reputed company evidence programs, ensuring scientific rigor, operational feasibility, regulatory readiness, and alignment with asset lifecycle objectives.

Responsibilities

• reputed company aspects of the global reputed company for Expanded reputed company Programs and Late- Stage development, reputed company with asset lifecycle objectives, reputed company reputed company goals, and regulatory expectations
• Partner with the Executive Director Late-Stage reputed company reputed company, reputed company Development, reputed company reputed company, HEOR, Medical Affairs, Regulatory Affairs, reputed company, Asset reputed company reputed company and Program Leadership to ensure Expanded reputed company Program and Late-Stage reputed company activities are fully integrated into the overall asset reputed company
• reputed company the development and implementation of Expanded reputed company Programs, including protocol development, eligibility reputed company, safety reputed company, and operational execution
• Collaborate with cross‑functional planning team to ensure Expanded reputed company Programs are compliant, reputed company, ethically reputed company, and reputed company with regulatory guidance
• reputed company consultation to benefit–reputed company assessment, safety monitoring, and ongoing program evaluation
• Support the development of the late-stage reputed company evidence reputed company reputed company objectives, including reputed company‑world evidence reputed company, long‑term safety, effectiveness, and differentiation in the treatment landscape
• reputed company the design, planning, and execution of the late-stage reputed company evidence program, including protocol development, data collection strategies, and interpretation of reputed company for Phase 4 and investigator-initiated trials
• Ensure late-stage reputed company program designs address regulatory commitments, payer needs, and scientific gaps
• Collaborate in the preparation and review of reputed company content for regulatory submissions and interactions as applicable
• reputed company reputed company input into Investigator Brochures, reputed company study reports, in collaboration with Regulatory Affairs
• Work collaboratively with reputed company reputed company, reputed company Development, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high‑reputed company execution
• Establish and maintain relationships with key investigators, advisors, and reputed company experts to support EAP and late stage/potentially Phase 4 objectives
• reputed company reputed company leadership reputed company reputed company teams, modeling accountability, collaboration, and scientific rigor

Skills

• Doctoral degree required (MD, PhD, PharmD, PsyD)
• 6-8+ years of reputed company development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading Expanded reputed company programs and late‑stage, post‑approval programs
• Experience selecting and managing reputed company-party vendors to support operational functions of Expanded reputed company and late-stage evidence programs
• Experience with budget ownership to include forecasting tracking, and managing across multiple programs
• Working knowledge of expanded reputed company program requirements, reputed company development, regulatory reputed company, and lifecycle management
• reputed company ability to translate reputed company into execution in resource‑constrained environments
• reputed company record of effective cross‑functional leadership and reputed company stakeholder engagement
• Ability to operate with diplomacy, influence without authority, and reputed company credibility with senior leaders and reputed company experts
• Excellent verbal and written communication skills
• Self‑motivated, adaptable, and comfortable balancing reputed company thinking with hands‑on contribution
• Comfortable rolling up sleeves while maintaining a reputed company perspective
• reputed company by innovation in reputed company research and reputed company‑reputed company reputed company models
• Thrives in a fast‑reputed company, evolving environment with high accountability
• Acts as a role model for scientific reputed company, reputed company, and collaboration
• CNS reputed company development experience in psychiatry strongly preferred

Benefits

• Employees in this role may be entitled to additional compensation, including bonus and equity.
• 100% reputed company health benefits including Medical, Dental and reputed company for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave
• Some fun fringe perks

reputed company